Published: 28 April 2021
Safety Information
Alert
Fluad Quad – a newly funded influenza vaccine for people aged 65 years and older
Fluad Quad is a vaccine approved to immunise people aged 65 years and older against influenza. It is not approved for use in people aged under 65 years, and safety in this group has not been evaluated by Medsafe. The Ministry of Health has been notified that Fluad Quad has been administered to a small number of people aged under 65 years. The Centre for Adverse Reactions Monitoring (CARM) has received two reports where Fluad Quad was administered to people aged under 65 years. However, there were no adverse events described in these reports.
Advice for consumers and caregivers
Information for healthcare professionals
Products affected
Further information
Useful links
Advice for consumers and caregivers
- Funded (free) influenza vaccines are currently only available for people aged 65 years and older.
- If you are aged under 65 years you can be vaccinated from 17 May 2021. It’s free if you’re at higher risk of getting very sick from the flu.
Information for healthcare professionals
- Fluad Quad is only approved for use in people aged 65 years and older.
- The use of Fluad Quad in people aged under 65 years is unapproved and can only be administered or prescribed by a medical practitioner. Unapproved use of medicines requires informed consent from the patient. Please refer to the Medsafe guidance on unapproved use of medicines.
- A different approved vaccine will be available for younger age groups.
- People aged under 65 years can be vaccinated from 17 May 2021. However, vaccines will be distributed to providers before this date.
Products affected
| Product name | Sponsor |
|---|---|
| Fluad Quad | Seqirus (NZ) Ltd |
Further information
Fluad Quad is an adjuvanted inactivated quadrivalent influenza vaccine. It is indicated for active immunisation against influenza in people aged 65 years and older. Each 0.5 mL dose contains 15 micrograms of each of the four influenza antigens recommended by the World Health Organization. The adjuvant, MF59, improves the immune response to the vaccine. In clinical trials of people aged 65 years and older, the antibody response to Fluad Quad was increased when compared to non-adjuvanted inactivated influenza vaccines. In clinical trials, the most frequently reported adverse events after Fluad Quad vaccination were injection site pain, fatigue, and headache. The majority of adverse events reported were mild or moderate in intensity and resolved within three days.
The 2021 Influenza Immunisation Programme started on 14 April 2021 with Fluad Quad for people aged 65 years and older. A different vaccine will be available for people aged under 65 years, and the programme will start on 17 May 2021.
Useful links
